Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

In accordance with the CLP criteria, skin sensitizer is defined as “a substance that will lead to an allergic response following skin contact”. To be classified as a skin sensitiser (Category 1) there must be evidence of chemicals’s sensitizing effects observed in substantial number of people.

In humans, contact dermatitis associated withReaction mass of 2,6-di-tert-butyl-p-cresol, 4,6-di-tert-butyl-o-cresol and 2,6-di-tert-butylphenol componentswere reported for some individuals. Therefore, based on the data summarised here,Reaction mass of 2,6-di-tert-butyl-p-cresol, 4,6-di-tert-butyl-o-cresol and 2,6-di-tert-butylphenol componentsare likely to cause allergy in susceptible individuals.

However, taken the small number of possibly affected, it is not sufficient to classify the substance in Category 1 Skin Sensitiser.

Respiratory sensitisation

Endpoint conclusion
Additional information:

In accordance with the CLP criteria, respiratory sensitizer is defined as “a substance that will lead to hypersensitivity of the airways following inhalation of the substance”. Generally, a substance is classified as respiratory sensitizer if there is evidence in humans that the substance can lead to specific respiratory hypersensitivity and/or if there are positive results from an appropriate animal test.

Currently, no recognized animal models for the testing of respiratory hypersensitivity are available.

Therefore, evidence that a substance can induce specific respiratory hypersensitivity will normally be based on human experience. However, no hypersensitivity reactions associated with exposure toReaction mass of 2,6-di-tert-butyl-p-cresol, 4,6-di-tert-butyl-o-cresol and 2,6-di-tert-butylphenol components were reported in humans.

In conclusion, based on the respiratory sensitization data summarized here and taking into account that there have been no reports of respiratory sensitization caused byReaction mass of 2,6-di-tert-butyl-p-cresol, 4,6-di-tert-butyl-o-cresol and 2,6-di-tert-butylphenol components, it is not considered to be a respiratory sensitizer.

Justification for classification or non-classification